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FDA 510(k)

3 Series Phototherapy Unit

K-Number: K153749 · 2016-06-30

ApplicantDaavlin Distributing Company
Decision Date2016-06-30
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3 Series Phototherapy Unit is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Company. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153749. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3 Series Phototherapy Unit?

3 Series Phototherapy Unit is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Daavlin Distributing Company. The 510(k) number is K153749.

When did 3 Series Phototherapy Unit receive FDA 510(k) clearance?

3 Series Phototherapy Unit received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153749.

Who is the listed applicant for 3 Series Phototherapy Unit?

The FDA 510(k) record lists Daavlin Distributing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Series Phototherapy Unit?

The FDA product code for 3 Series Phototherapy Unit is FTC.

Other records listing Daavlin Distributing Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233811DT Controlled Phototherapy EquipmentK2303823 Series NeoLuxK2208401 Series Phototherapy EquipmentK2125107 Series Phototherapy DeviceK210881M Series Phototherapy EquipmentK182215ClearLink Controlled Phototherapy Equipment

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Related Devices (Code: FTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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